White Paper

Self Emulsifying Drug Delivery Systems (SEDDS): A Promising Approach To Improve Oral Bioavailability Of Poorly Soluble Compounds

By Hemang Joshi, Head of Formulation & Development, Drug Product Operations, Eurofins CDMO Alphora

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Poor water solubility is not a niche problem. It affects roughly 40% of new chemical entities and more than 90% of currently marketed drugs, making it one of the most persistent challenges in oral drug formulation. Self-emulsifying drug delivery systems, or SEDDS, offer a well-established but still underutilized path forward, and understanding how to deploy them correctly matters more than most formulators initially expect.

Written by Hemang Joshi, Head of Formulation Development at Eurofins CDMO Alphora, this analysis walks through the full SEDDS toolkit: the Lipid Formulation Classification System (LFCS) types I through IV, the role of oils, surfactants like polysorbate 80, co-surfactants, and precipitation inhibitors such as hydroxypropyl methylcellulose and poloxamers. One point worth sitting with: SEDDS aren't just for classic "grease ball" molecules with log P above 3. Transformation of "brick dust" compounds into lipophilic salts can bring them into range too.

The piece also covers evaluation methodology, including dispersion kinetics, particle size analysis via Dynamic Light Scattering, in vitro lipolysis using porcine pancreatic extract, and how pseudo-ternary phase diagrams guide excipient ratios. If you're working through a bioavailability problem on a BCS Class II or IV compound, download the full analysis to map the right SEDDS strategy for your molecule.

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